Reconstituted high density lipoprotein used in patients with acute coronary syndrome (ACS) may reduce atherosclerotic plaque burden, thereby reducing the risk of recurrent cardiovascular events. This study is a multi-center, randomized, placebo-controlled, single ascending dose study in patients with stable atherothrombotic disease in whom the safety and pharmacokinetic profile of CSL112 will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
45
Single escalating intravenous doses of CSL112
Single intravenous doses of normal saline (0.9%)
Study Site
Chula Vista, California, United States
Study Site
Jacksonville, Florida, United States
Study Site
Miami, Florida, United States
Study Site
Safety
The frequency of study product-related adverse events
Time frame: 14 days
Clinically significant elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
Number of subjects with clinically significant elevation of ALT or AST
Time frame: 14 days
Pharmacokinetic profile of apolipoprotein A-I (apoA-I)
Plasma apoA-I concentration with and without baseline correction
Time frame: 9 days
Plasma apoA-I area under the curve (AUC)
Time frame: 9 days
Plasma apoA-I Cmax
Time frame: 9 days
Plasma apoA-I Tmax
Time frame: 9 days
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Lexington, Kentucky, United States
Study Site
Madisonville, Kentucky, United States
Study Site
Auburn, Maine, United States
Study Site
Baltimore, Maryland, United States
Study Site
Petoskey, Michigan, United States
Study Site
Durham, North Carolina, United States
Study Site
Philadelphia, Pennsylvania, United States
...and 1 more locations